Inflammasome Therapeutics Reports Promising Results from K8 Implant Trial for Geographic Atrophy

Inflammasome Therapeutics has announced encouraging 3-month topline results from a clinical trial evaluating its K8 implant for patients with geographic atrophy (GA). Conducted at the University of Kentucky (NCT06164587), the study highlights significant efficacy and safety following a single injection of K8.

Key Findings

Reduction in GA Lesion Growth

       • 66% Reduction: The K8 implant reduced the mean growth of GA lesions by 66% in treated eyes compared to untreated contralateral eyes (p=0.029, mixed effects model).

       • The data were analyzed using fundus autofluorescence (FAF) imaging by an independent masked reading center.

       • Lesion growth was substantially slower in K8-treated eyes across all patients.

Safety Profile

       • No drug-related intraocular or systemic safety concerns were observed in the initial cohort of five patients.

Expanded Trial

Following these results, the study has been expanded to include 30 patients (60 eyes). Participants will receive a second K8 injection at the 3-month mark during this 6-month study to further evaluate safety and efficacy.

Expert Commentary

Dr. Jayakrishna Ambati, co-founder of Inflammasome Therapeutics, expressed enthusiasm over the rapid and significant efficacy:

“Natural history studies reveal that lesion growth rates in both eyes of bilateral GA patients differ by less than 5%. Therefore, achieving a 66% reduction in treated eyes is strong evidence of efficacy. K8’s unique mechanism of action, which targets complement activation and other inflammatory pathways, underscores its potential as a transformative therapy for GA.”

Dr. Ambati also highlighted the broad applicability of K8, noting that reductions in lesion growth were observed regardless of disease patterns, lesion location, or other AMD characteristics.

Dr. Paul Ashton, CEO and co-founder of Inflammasome Therapeutics, emphasized K8’s potential to surpass existing therapies:

“These results demonstrate the potential for K8 to break through the efficacy ceiling observed with existing FDA-approved anti-complement therapies, which achieve only modest reductions in lesion growth after a year of monthly injections. The significant 66% reduction observed with just five patients is indicative of K8’s robust effect and supports our belief in its superior therapeutic profile.” 

Next Steps

The next phase of the trial will focus on:

       • Safety and efficacy in up to 30 patients.

       • Evaluating GA lesion growth reduction and safety outcomes over 6 months with injections administered every 3 months.

Conclusion

The K8 implant demonstrates significant potential to transform the treatment landscape for geographic atrophy, offering rapid and dramatic lesion growth reduction with fewer injections compared to existing therapies. As the trial progresses, K8 could emerge as a groundbreaking option for patients facing this debilitating condition.